Update: RenAvast Banned by the FDA Due to Illegal Claims

Last year, I wrote about a supplement marketed for dogs and cats with kidney failure, RenAvast. AT the time, the Bottom Line conclusion for this supplement was this:

The ingredients in RenAvast™ are deliberately not disclosed by the company beyond the fact that they are amino acids and some sort of peptide. Therefore, it is impossible to evaluate the plausibility of the proposed mechanisms of action or any preclinical research on these ingredients.

The only data presented for safety and efficacy is a poor quality, small trial with clear and significant risk of bias that is essentially useless as evidence. There are, of course, plenty of testimonials and anecdotes suggesting the product works, but that is true for every therapy ever invented, so either no idea in medicine ever fails, or anecdotes are very reliable.

There is no way to determine at this point if the product is safe or effective. However, the way that it has been marketed shows a clear disregard for both the regulations intended to prevent inappropriate and unproven claims for dietary supplements and the basic principles of medical research. The combination of secrecy and misuse of sloppy science suggests a great deal of skepticism is in order when dealing with this company and its products.

I also pointed out that in 2012, the FDA had warned the company about making illegal claims about the safety and efficacy of the product which had not been proven by appropriate clinical trials. Clearly, as of last year the company was still ignoring the law and defying this warning. Well, the wheels of regulatory enforcement turn slowly, but three years later the FDA has finally taken action against this firm:

On July 10, 2015, the United States District Court for the District of Nevada entered a consent decree of permanent injunction against Bio Health Solutions LLC, of Las Vegas and its manager and co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug.

According to the complaint filed with the consent decree, the defendants have marketed RenAvast to treat diseases, including chronic renal failure, in cats and dogs. It is illegal to market new animal drugs without first requesting FDA pre-market review and obtaining legal marketing status. The FDA pre-market review process evaluates whether products are safe and effective for their intended use, can be consistently manufactured, and are truthfully and completely labeled.

The decree, filed on FDA’s behalf by the U.S. Department of Justice’s Consumer Protection Branch and the U.S. Attorney’s Office for the District of Nevada, prevents Bio Health Solutions LLC and Garrison from introducing RenAvast and any other unapproved new animal drugs into interstate commerce. The firm would not be able to market the drug unless and until it obtains an approved new animal drug application or meets the requirements for an investigational new animal drug exemption.

“The Federal Food, Drug, and Cosmetic Act’s new animal drug approval requirements provide important protections for consumers and their animals,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine. “We believe consumers should be able to trust that the drug products they administer to their pets have been proven to be safe and effective.”

It remains to be seen how the company will respond to this legal injunction, but hopefully this product will be taken off the market until and unless real clinical trial evidence is available to establish any risks or benefits it has. Sadly, that leaves scores of other similar products out there, but it is good to see that at least occasionally the FDA is willing to take action to prevent such flagrant illegal marketing of snake oil to pet owners.

60 Responses to Update: RenAvast Banned by the FDA Due to Illegal Claims

I called the company when I found I could no longer buy the product online. They told me they were replacing Renavast with Aminavast. I ask why the name was changing. They told me it was a reformulation. I asked why the name change then. They said it was due to a copy right issue. I then asked how it was reformulation and what was in it. They said it was proprietary. I still ordered the Aminavast. My dog has been on it for a year. It has been a combined two years with Renavast/Aminavast and he has greatly improved… Though we did change to a prescription diet at the same time. Today, I went to order more Aminavast and IT IS NO LONGER AVAILABLE! From this post, I now know why. I’ve spent thousands of dollars on this medication. I will live with that as long as what IS in it has not harmed my dog.

I have used this medicine (starting w/ Renavast) for over 3 years. It DID save my cats life! She was diagnosed w/ kidney failure at age 14 yrs and 2 vets recommended putting her down. That gut feeling (& lots of prayers) said “not yet”. My cat seemed to still be fighting to live. So after a lot of searching, I found Renavast. The customer service was superb! They walked me through many helpful suggestions and after finding a NEW vet as well, we gave my kitty fluids and Renavast! Within 2 months, the cat was not on ANY other medicine except Renavast! (she was on antibiotics as well up until this pt). Her blood work which I had done regularly due to the kidney failure, was back to normal….YES, NORMAL! My cat recently passed away in May, one month shy of her 18 b-day. She did NOT die from kidney failure. My cat is living proof that this does work! Also, my moms 17 year old cat has been on it for over 2 years w/ similar results. This did extend my cats life and quantity of life. Don’t fight to get this banned. Fight to get this approved! It’s an excellent product! My cat is proof!

As I am forced to remind people constantly, anecdotes don’t prove anything. I have seen hundreds of cats in my career who did just as well as your without this product, so what does that eman?

Such anecdotes don’t prove a this product works just as they don’t prove that bloodletting, homeopathy, prayer, or ritual sacrifice work. Every treatment ever invented has generated stories of apparent success, so anecdotes are the test that nothing every fails. Yet the reality is, some treatments don’t work, so if anecdotes always say they do, then we can’t trust anecdotes.

I encourage you to read these articles that discuss in much more detail why anecdote simply don’t help us evaluate medical treatments.

Hi there!
I love this blog because you helped me once before. My dog had a heptocellular carcinoma and had two liver lobes resected. You helped me evaluate the evidence for using Denamarin and Vitamin E in lieu of other treatments. Because of the fact there’s no really clinically tested treatment for hastening hasten liver regeneration and the evidence you sent me shows neither could do real harm, I kept her on both and her ALT and AlkPhos eventually returned to normal levels within the general time frame found in liver lobectomy studies (maybe not due to the combo, but the combo certainly didn’t prevent liver regeneration.)

I came here to check out RenaVast/AminaVast as it was suggested by my vet for a fospice cat with chronic kidney disease that I took in at 17 years old. It really pains me to see that this product was marketed without FDA evaluation. Do you have ANY sense at all of the ingredients? Do you feel comfortable making a guess about this products’ potential harm? I really love my vet, and I don’t believe he would ever knowingly suggest anything that could hurt my furry friends. But I’m a little worried about the fact this company has held the formula as proprietary and has not allowed any of their research to be replicated by the FDA and anyone else. “Knowingly” is the key.

Realistically, because I love this little animal, as long as it has no potential for harm and no obvious side effects (I’ve added it to her diet and am carefully monitoring her ), for $25 a month I may keep giving it to her unless something else changes in her condition like a new medication needs to be added or something else. If there is really no potential for harm and clinically speaking I’m just throwing my money away, I do (perhaps irrationally) find utility in being able to tell myself “you did everything you could.” It makes that final step in the treatment plan emotionally easier to bear which I think leads to better decisions on behalf of the animal. BUT if anyone tells me any active ingredients here have been shown to cause harm OR there’s even anecdotal evidence of harm then that immediately outweighs any benefit and I’ll remove it from the chronic kidney failure regime of “commercial renal diet + electrolyte monitoring/imbalance corrections + SubQ fluid hydration + hypertension control.” Sadly this may not be true if the makers of the product would submit to FDA review and allow other researchers to attempt to replicate their results. But since they have chosen not to do that, I’m taking a hard line and will probably discontinue based on anecdotal harm.

I’m glad to hear your dog did well, and sorry that you are now dealing with kidney disease in your kitty. As you see from the article, the harm potential is difficult to assess since the company won’t say what is in the product. The ingredients I did find listed on a site not affiliated with the company basically just included amino acids, which are in any protein your cat eats in its food. If this is true, then the product contains essentially nothing your cat isn’t already getting. These would be harmless, but completely worthless.

On the other hand, if there are other ingredients not disclosed, who knows whether they are safe or not?

Finally, I would always be reluctant to support a company willfully violating the law and ignoring an FDA order to cease selling their product. It’s clear such a company cares more about profit than the well-being of our pets and cannot be trusted.

We used RenaVast/AminAvast for one of our older cats with chronic renal failure, and my mom’s old cat with CRF, as recommended by our vet. She has been in practice for almost 30 years working exclusively with felines. She has been our vet for 16 years. I noticed after being on it they both ate better, quit vomiting, and gained some weight back. After six months we had their blood work re-checked. It showed their kidney function numbers had in fact improved quite a lot. My cat lived another two years and Mom’s another three years before their kidney function dropped again. They showed no adverse effects clinically or on their lab work. So I would say RenaVast did help extend the quantity and quality of life for both cats.

Always good to hear about patients that do well, but I could easily provide stories of similar outcomes without this product and with use of everything from no treatment to faith healing. Such anecdotes aren’t as reliable or conclusive as they appear. Here is some more detailed discussion of why:

I’m just curious why Aminavast is considered a drug instead of a nutraceutical, and thus not subject to regulation like most of the other untested and unproven nutraceuticals in human and veterinary fields. I acknowledge that a study of 59 cats is not impressive, but it does seem to help my patients with chronic renal failure. The difficulty is that I never have used it as a sole therapy.

The issue is that the law governing nutraceuticals (The Dietary Safety and Health Education Act or DSHEA) specifically forbids any claims that a supplement can aid in the diagnosis or treatment of a disease. Only vague claims of “support” for normal body functions or nutritional claims can be made. The claim that it treats kidney disease is what makes it subject to the standards of proof for safety and efficacy required for drugs. Sadyly, you can sell almost anything without proving it is safe or that it works so long as you are careful not to directly claim it treats a disease.